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Fakes Infiltrate Injectable Drugs

News that a counterfeit version of the cancer drug Avastin was found in the U.S. highlights a rising threat: fakes of costly injectable therapies, rather than simple pills, such as Viagra.

The Food and Drug Administration recently alerted doctors and other health-care providers about the risk of "non-FDA-approved injectable cancer medications," including unauthorized versions of Herceptin, Rituxan and Neupogen, that were being marketed and sold to clinics and "most likely were administered to patients."

A vial of Avastin
Genentech/Associated Press

A counterfeit vial of Avastin
Genentech/Associated Press

On Jan. 13, the FDA also alerted British drug maker
AstraZeneca
PLC to "a number of cases of illegal importation of oncology drugs into the U.S.," including AstraZeneca's injectable cancer drug Faslodex, according to the company.

The FDA said this unapproved Faslodex was "most likely" administered to patients. AstraZeneca said it has "no evidence" that the illegally imported drug entered the legitimate supply chain in the U.S. or elsewhere.

A spokeswoman for
Amgen Inc.,
maker of Neupogen, said it isn't aware of any counterfeits of its products on the U.S. market and is cooperating with an FDA investigation of illegal imports of an unidentified product, not approved for sale in the U.S., that is being sold on the Internet and directly to clinics.

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In the past, most drug-counterfeiting incidents have involved pills such as the erectile-dysfunction medicine Viagra, the most commonly faked drug, according to its maker,
Pfizer Inc.,
with more than 9.5 million bogus tablets seized last year. Increasingly, however, complicated therapies like Avastin, which is given intravenously, are being faked, drug makers say.

Injectable drugs have become increasingly attractive to counterfeiters, in part because they often fetch a higher price than regular pills. Avastin, made by
Roche Holding's
Genentech unit, costs $2,400 a vial.

Hugh Pullen,
associate director for European government affairs at
Eli Lilly
& Co., said the faking of such products is a "growing phenomenon" and something Lilly is "looking at very closely."

Counterfeiters "are going after anything and everything, from patented to non-patented, expensive to inexpensive," said
John Clark,
Pfizer's chief security officer. Last year, counterfeit Viagra accounted for 85% of the seized fake Pfizer drugs, down from a high of 95% when counterfeiting emerged as a serious threat in the late 1990s.

The number of reports of counterfeited injectable biological drugs, such as Avastin, is still small. But they have more than doubled to 4% of the world-wide total of reported counterfeiting incidents between 2009 and 2005, according to the most recent data collected by the Pharmaceutical Security Institute, a nonprofit group that works on behalf of drug makers. A third of the counterfeit injectables were cancer treatments.

In 2009, the group identified 2,003 drug-counterfeiting incidents world-wide, based on law-enforcement actions, regulators' warnings and company announcements that fake drugs had been discovered.

The faking of injectable drugs is particularly worrisome to health-care providers because they tend to be life-savings medications for conditions such as cancer, rather than so-called lifestyle drugs, such as Viagra.

In the case of Avastin, the discovery of counterfeits has prompted clinics and hospitals in the U.S. to scrutinize their supplies. So far, the FDA says it hasn't received any reports of cancer patients injured by the counterfeit Avastin.

The agency has warned 19 medical clinics, most in California, that they may have bought counterfeit Avastin.
Connie Jung,
an official in the FDA's drug compliance office, described the threat as limited.

"This only affects a small subset of cancer patients" whose doctors purchased the illegitimate drugs, she said.

The source of the fake drug hasn't been determined, but European and U.S. authorities said Wednesday they were looking into its path from a supplier in Switzerland through a Danish wholesaler and then to a British wholesaler, before a Tennessee company sold it in the U.S.

Britain's Medicines and Healthcare Products Regulatory Agency said it found that 41 out of 167 packs of counterfeit Avastin the British drug wholesaler bought from its Danish counterpart already had been sold to the U.S. The agency quarantined the packs that remained at the British company.

The FDA identified the British wholesaler supplying the U.S. as Quality Specialty Products, which it said may also be known as Montana Health Care Solutions. The company couldn't be reached for comment.

While experts say the U.S. drug supply remains safe, unapproved drugs can enter through purchases from Internet pharmacies or unauthorized suppliers. In the absence of a monitoring system, they then can make their way undetected through the network of wholesalers and distributors that furnish medicines to doctors and conventional pharmacies.

"We don't have any system in place for authenticating drugs in the U.S.," said
Allan Coukell,
director of medical programs at the Pew Health Group, who co-wrote a report last year on counterfeit and adulterated drugs. He said federal laws don't require the tracking and tracing of medicines, though companies are developing a plan, and California has a law that starts taking effect for manufacturers in 2015 .

Last year Europe adopted legislation requiring each pack of drugs to carry a unique serial number. When the legislation comes into force in 2016, pharmacists and hospitals will be required to scan the bar code to ensure the product is legitimate.

Many drug makers have taken their own steps to curb counterfeiting. Pfizer has a global security team including former U.S. Federal Bureau of Investigation and Turkish narcotics agents, Hong Kong police and U.K. law-enforcement personnel to conduct undercover purchases and do other investigations. It shares the results with authorities in various countries.

China and Jordan now are investigating the counterfeiting of Pfizer drugs based on a company investigation, the company's Mr. Clark said.

When three counterfeiters in an Asian country began selling fake versions of its drugs,
Abbott Laboratories
arranged a sting by forming fake businesses, said Doug Frazier, head of Abbott's protection group. He declined to identify the country but said Abbott arranged for local law enforcement to arrest the suspects.

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Because they are often administered in hospitals, by nurses or doctors, injectable drugs are harder to sneak into the supply chain than pills, industry experts say. Britain's MHRA said the Avastin counterfeiting marks only the second time it has come across counterfeit injectable medicines in the legitimate supply chain. A spokeswoman for the European Medicines Agency called it "very rare."

Nevertheless, hospitals and clinics attempting to "cut corners" might buy drugs from "more of a gray-market distributor than might be wise," said
Mark Davison,
an industry consultant and author of the book "Pharmaceutical Anti-Counterfeiting: Combating the Real Danger from Fake Drugs." He pointed to a case from the early 2000s when counterfeit Epogen, an injected anemia drug, made its way into Florida's health-care system.

Typically, counterfeiters target doctors through email spam campaigns or "fax blasts" offering discounts on drugs administered at their offices or in hospitals, said
Thomas Kubic,
the Pharmaceutical Security Institute's president and chief executive.

Foreign distributors, posing as legitimate drug wholesalers, may team up with local salespeople to recruit new physician customers, Mr. Kubic said. Those wholesalers usually get conventional drugs from legitimate Indian or Chinese generic drug manufacturers that make compounds that are not approved in the U.S.

The Danish Medicines Agency appears to have been the first regulator to notice the counterfeit Avastin. It reported to Britain's MHRA on Dec. 15 that a Danish wholesaler had purchased the fake medicine from a Swiss company and then sold it to a U.K. firm, according to British and Danish drug regulators. After finding that counterfeit packs had been sold to the U.S., the MHRA said, it told the FDA on Dec. 22.

The MHRA said there is "no evidence" that British patients received counterfeit Avastin, but that it is still investigating the matter. It added that it doesn't know where the fake product was produced.

The FDA collected the suspect vials and, working with Genentech, confirmed through testing that they were counterfeit, said the FDA's Ms. Jung. After receiving the confirmation this week, the agency decided to warn doctors and hospitals about the fakes, she said.